Engineering Assoc Manager

Responsible for leading manufacturing engineering activities across assigned operations, including process development, process validation, equipment management, continuous improvement, quality system compliance, and operational support. Provides leadership and direction to engineers, technicians, and other technical personnel to ensure achievement of safety, quality, delivery, and cost objectives. Leads complex engineering initiatives and cross-functional projects that support operational excellence, business growth, and regulatory compliance.

Work in collaboration with Engineering Director

Leadership & People Management

Plan, prioritize, and review work assignments.

Coach, mentor, and develop engineers, technicians, and programmers.

Build an engaged, high-performing engineering team.

Serve as a technical leader across manufacturing operations.

Manufacturing Process Excellence

Develop, improve, validate, and sustain manufacturing processes.

Lead manufacturing and End-Of-Line improvements.

Drive quality, throughput, scrap reduction, and cost improvements.

Use statistical methods and continuous improvement tools.

Monitor manufacturing performance.

Lead | Support VIP & Cost Saving Program across manufacturing sites.

Technical & Engineering Leadership

Solve complex manufacturing and process issues.

Lead equipment acquisition, implementation, and optimization.

Support new product introductions and validation activities.

Lead large cross-functional engineering projects.

Strengthen P&PC – Production and Process Controls & Validation Acumen

Quality & Compliance

Lead CAPA, nonconformance, and change management activities.

Maintain compliance with GMP, ISO, MDR/MDD, and internal quality systems.

Support audits and regulatory inspections.

Having at least one year of experience managing a team

Direct experience in the Medical Device Industry

BA in an engineering or computer science discipline

Bachelor’s degree in another field with related certifications (e.g. CMM, CQE) plus 5-7 years’ experience in engineering, quality or regulatory compliance role.

Extensive knowledge of the Quality System Regulation and Associated regulations and standards.

Experience with control procedures, such as the Change Management System, Nonconformance Reports, Engineering Specifications, Corrective and Preventive Action (CAPA), and Work Instructions

Demonstrate exceptional written and verbal communication exhibiting high-level technical expertise, tact and discretion, and keep management appropriately informed

Up to 30% to various sites: Dover, OH, Braintree MA, Jacksonville, FL and Norfolk, VA

Salary Expectations:

$110,000 - $135,000 USD

EOE/M/F/Vet/Disability